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This is a prospective, single-arm, multi-center, observational, post-market registry to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months.
Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm clinical investigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitaFlow Liberty™ Transcatheter Aortic Valve System | Device | Transcatheter Aortic Valve Replacement with VitaFlow Liberty™ Transcatheter Aortic Valve System. Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite rate of all-cause mortality and stroke with disability | Composite rate of all-cause mortality and stroke with disability | 12 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcomes defined by VARC3 | Rate of all-cause mortality, myocardial infarction, stroke, implanted related new and/or worsen conduction disturbances and arrhythmias, new permanent pacemaker implantation, procedure-related or valve-related hospitalization defined by VARC 3. | 30 days, 12 months, and 2-5 years post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luying Yan | Contact | 86-010-66513642 | lyyan@microport.com | |
| Zhujun Cai, PhD | Contact | 86-021-38954600 | zjcai@microport.com |
| Name | Affiliation | Role |
|---|---|---|
| Darren Mylotte, MD | Galway University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galway University Hospital | Not yet recruiting | Galway | Ireland |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Safety outcomes defined by VARC3 |
Rate of type 2-4 bleeding, major vascular and access-related complications, acute kidney injury (stage 2-4) defined by VARC 3 |
| 30 days and 12 months post procedure |
| Safety outcomes defined by VARC3 | Rate of other acute procedural and technical valve related complications: conversion to surgery; unplanned use of mechanical circulatory support; implantation of multiple (>1) transcatheter valves during the index hospitalization; valve mal-position | acute procedure (within 24 hours) |
| Device success | Device success defined by VARC 3 | 30 days post implantation |
| Device early safety | Device early safety defined by VARC 3 | 30 days post implantation |
| Bioprosthesis haemodynamic function | Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2). | Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation |
| Bioprosthesis haemodynamic function | Bioprosthesis haemodynamic function (assessed by echocardiography) including mean transvalvular gradient (mmHg). | Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation |
| Bioprosthesis haemodynamic function | Bioprosthesis haemodynamic function (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total). | Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation |
| Bioprosthetic valve dysfunction | Moderate or severe haemodynamic valve deterioration defined by VARC3 | 12 months and 2-5 years post procedure |
| Bioprosthetic valve dysfunction | Bioprosthetic valve failure defined by VARC3 | 12 months and 2-5 years post procedure |
| Bioprosthetic valve dysfunction | Clinically significant valve thrombosis defined by VARC3 | 12 months and 2-5 years post procedure |
| NYHA Classification | Changes in cardiac function at discharge, 30 days and 12 months and 2-5 years post implantation according to the NYHA Classification Scheme compared to baseline | From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure |
| Ospedale Cisanello | Recruiting | Pisa | Italy |
|
| Hospital Universitario de a Coruna | Recruiting | A Coruña | Spain |
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| Hospital Clínico San Carlos | Recruiting | Madrid | Spain |
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| Hospital clinico Universitario de Valladolid | Recruiting | Valladolid | Spain |
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| Luzerner Kantonsspital | Herzzentrum | Recruiting | Lucerne | Switzerland |
|
| D014694 |
| Ventricular Outflow Obstruction |